Senior Quality Engineer NPD

Johnson & Johnson Innovative Medicine•Irvine, CA

8d•$79,000 - $127,650•Onsite

About The Position

The Senior Quality Engineer plans, coordinates, and executes quality assurance activities to ensure effective product quality processes throughout the product lifecycle. This role is involved in New Product Development (NPD) teams, developing products, designing verification tests, process validations, and quality processes to ensure compliance with the company’s Quality System policies, procedures, and applicable external requirements and standards. The engineer will assist in developing quality-engineered systems and products, and support qualification and validation activities. This position is considered a subject matter expert (SME) on Quality matters and relevant Quality tools, working on complex problems and projects. The role requires leadership in driving programs/projects, innovating compliant approaches and solutions, and sharing technical expertise with others while developing other engineers. Collaboration with other members of the Design Team is expected, contributing to activities such as risk management document development, creation and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.

Requirements

Bachelor’s degree, required; preferably in engineering and/or scientific discipline
A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
Ability to apply project management skills to ensure fulfillment of new product development requirements
Ability to develop and implement Quality standards
Demonstrated auditing and problem-solving skills
Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
Lean manufacturing experience
Knowledge of Quality and operations systems and processes, including GMP

Nice To Haves

Working knowledge of CAD software (Solidworks, AutoCAD)
Working knowledge of SolidWorks, other CAD based programs (i.e.. basic dimensioning, tolerance stack analysis) is a plus.
Experience with Minitab, R and other statistical software is a plus.
Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.

Responsibilities

Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
Technical problem solving, failure analysis, and root cause determination.
Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Recommend issue resolution to management for significant capability and compliance issues.
Works closely with functional leadership in planning and executing project milestones.
Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features.
Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year